Means to inject a plastic into a cavity to produce a replica thereof

ABSTRACT

The particular embodiment of the invention disclosed herein is specifically designed to produce a soft resilient plastic impression of the interior configuration of a body cavity, the invention having special utility for the purpose of medical diagnosis for exploring the lower portion of the large intestine. For this purpose, the invention provides a catheter for insertion into the body cavity in combination with a disposable cartridge containing isolated ingredients of a fast curing polymer, the cartridge being adapted for rapid preparatory intermixture of the ingredients and immediate extrusion of the mixture to and through the catheter.

United 1 States Patent Cook et al.

[54] MEANS TO INJECT A PLASTIC INTO A CAVITY TO PRODUCE A REPLICATHEREOF [72] Inventors: Ralph J. Cook, Torrance; Clifford C. Moline,Malibu; Joseph M. Schumann, Inglewood, all of Calif.

[73] Assignee: Products Research 81 Chemical Corporation, Burbank,Calif.

[22] Filed: March 7, 1967 211 Appl. No.: 621,174

52 U.S. c1. ..12s/2 11, 128/246, 128/349 13 [51] 1111.01. ..A6lb 05/10[58] Field of Search ..128/2, 21:; M, 218 NV, 220, 128/230, 234, 235,237, 240-246, 276, 344,

[56] References Cited UNlTED STATES PATENTS 2,330,399 9/1943 Winder..128/349 2,804,075 8/1957 Borden ..128/277 3,459,175 8/1969 Miller..128/2 1,924,916 8/1933 Drake ..128/234 2,457,244 12/1948 Lamson..128/246 2,676,591 4/1954 FOX 1 51 Dec. 26, 1972 6/1956 Wallace..128/295 2,869,543 1/1959 Ratclit'f et al. ..123/218 M 2,869,544 1/1959Ratcliff et al ..128/220 3,144,966 8/1964 Cook ..222/136 3,164,3031/1965 Trautmann 222/136 X 3,195,778 7/1965 Coates ..222/1 36 X3,247,841 4/1966 Cook 128/2 3,370,754 2/1968 Cook et al 128/218 M XPrimary Examiner-Dalton L. Truluck Attorney-Smyth, Roston & Pavitt [57ABSTRACT The particular embodiment of the invention disclosed herein isspecifically designed to produce a soft resilient plastic impression ofthe interior configura- -tion of a body cavity, the invention havingspecial utility for the purpose of medical diagnosis for exploring thelower portion of the large intestine. For this purpose, the inventionprovides a catheter for insertion into the body cavity in combinationwith a disposable cartridge containing isolated ingredients of 24Claims, 9 Drawing Figures PATENTED DEC 26 1912 SHEEI 1 OF 3 p 3% Mm wan.

M M m ca r 4 6 r in 4. 5

PATENTED w: 2 I912 3. 707. 146

' sum 2 or 3 Jars ab M 5651/014/7/7 MEANS TO INJECT A PLASTIC INTO ACAVITY TO PRODUCE A REPLICA THEREOF BACKGROUND OF THE INVENTION Broadlydescribed the invention is a means for injecting a fast curing plasticinto a cavity to produce a replica of the interior configuration of thecavity where the shape of the cavity would make it impossible towithdraw a rigid replica from the cavity. The required replica isproduced by a plastic that cures to form a soft resiliently deformableplastic body that is capable of yielding in shape as required forwithdrawal and when withdrawn may be relied upon to return to the exactconfiguration of the cavity.

Medical diagnosis by this procedure has now become possible by thedevelopment of a plastic material that has the following necessarycharacteristics: (1) physiologically inert in the sense of beingharmless to internal surfaces of the human body; (2) sufficiently fluentin uncured state for extrusion from a dispensing container into a bodycavity; (3) quick setting to cure in a short time period, preferablywell under 5 minutes;

(4) capable of being molded to stable solid state by A surfaces; (5)rubber-like when cured and sufficiently soft and resilient for yieldingdistortion as required for withdrawal through restricted portions of thebody cavity without physical harm to the tissues and without unduediscomfort to the patient and capable after such distortion of returningto precisely the configuration of the cavity. A suitable plastic forthis purpose that is produced by The Dow Chemical Co. and is availablefrom Travenol Laboratories Inc., Morton Grove, lllinois, is apolysiloxane foam produced by catalyzing a silicon polymer by stannousoctoate; Mixing together the polymer and catalyst produces a fluentuncured plastic which begins to cure in less than 1 minute andcompletely cures in approximately 3 minutes.

One subcombination of the structure for practicing the invention is asuitable catheter'through which the uncured plastic is extruded from adispensing container into a body cavity such as the lower portion of thelarge intestine. It has heretofore been proposed to provide such acatheter with a guard flange to limit the extent to which the cathetermay be inserted into a body cavity and it has also been proposed toprovide the catheter with an enlargement for the dual purpose ofretaining the catheter in the body cavity and of preventing reverseextrusion of the uncured plastic out of the body cavity. It has beenfurther proposed to provide such an enlargement in the form of a thinwalled cuff that may be collapsed to facilitate insertion of thecatheter and after insertion may be inflated to an effective size by anexternal means, for example, by a pump in the form of an elastomer bulb.

One problem relating to such a catheter that is solved by the presentinvention is that while such an enlargement is effective for its twopurposes, nevertheless it cannot be depended upon to prevent leakagefrom the body cavity of small amounts of fluid including body fluids andresiduals of fluids previously introduced to evacuate the cavity inpreparation for the molding operation.

Another problem solved by the invention arises from the fact that apassage space of substantial volume exists between the dispensing portof the container and the nozzle of the catheter. Displacement of the airfrom this passage space into the body cavity by extrusion of the plasticinterferes with the injection of the plastic and results in trapping ofair in the cavity with consequent deformation of the molded plastic.

A second subcombination of the invention is a dispensing container inthe form of a disposable cartridge that stores the polymer and catalystin separate compartments and is adapted not only for intermixing the twoingredients but also for connection to the catheter for prompt extrusionof the uncured plastic into the body cavity.

Examples of multiple compartment disposable cartridges capable of mixingand dispensing uncured plastic are disclosed in the Cook U.S. Pat. No.3,144,966 in Class 222, Sub Class 136 and in the Cook U.S. Pat. No.3,153,531 in Class 259, Sub Class 113. While these priorvart cartridgesare effective for their intended purposes of mixing and dispensingsealants for industrial use they are not suitable for the presentinvention because of the requirement that the separate ingredients bethoroughly intermixed and dispensed into the body of the patient withinthe total time period of 45 seconds. In both disclosures of the twoabovementioned Cook patents, the ingredients are intermixed by a dasheron an operating rod that extends through the dispensing port of thecartridge and normally closes the dispensing port. Consequently, theoperating rod must be withdrawn to open the dispensing port afterthemixing operation and in addition further manipulation of the cartridgestructure is required to ready the cartridge for actual extrusion of theuncured plastic.

An important problem to which the present invention is directed is toavoid these disadvantages by providing a disposable dispensing cartridgethat may be manipulated in a simple and convenient manner to intermixthe different ingredients and to dispense the mixture, all within 30seconds without requiring specialized skill or even experience andpractice. This problem involves the more specific problem of providing asimple, reliable, fool-proof and easily explained step-by-step procedurefor producing the desired diagnostic plastic replica.

Other more specific problems to which the invention is directed include:elimination of the need for manipulating a dasher by means extendingthrough the dispensing port of the cartridge so that the dispensing portmay be continuously available for transferring the uncured plastic tothe catheter; the problem of providing an operating rod that may befreely reciprocated through a dispensing piston independently of thepiston to actuate a dasher beyond the dispensing piston, which operatingrod may be subsequently directly connected to the dispensing piston forthe purpose of extruding the plastic mixture; the problem of providing apositively locked dispensing valve to prevent premature extrusion of themixture through the dispensing port of the cartridge without the penaltyof losing precious time to unlock the valve; the problem of enabling thenormally closed dispensing valve to open automatically in response tothe step of connecting the cartridge to the catheter; the problem ofproviding a dispensing cartridge in which the mixing operation may becarried out while the cartridge is connected to the catheter, thusmaking it possible to connect the cartridge in advance if it is desiredto eliminate the necessity of making the connection during the allowed30 seconds; and the problem of constructing the catheter and dispensingcartridge so economically that the whole combination may be disregardedafter one use to avoid the need for cleaning and sterilizing thecombination for repeated use.

SUMMARY OF THE INVENTION the guard flange and the body of the patient toaccommodate a suitable sponge and by providing such a sponge in the formof a collar made of foamed plastic or the like. Such a collar may beeasily mounted on the catheter or removed from the catheter while thecatheter enlargement is deflated. The sponge collar not only capturesand retains the leakage fluid but also serves as a cushion for theflanged guard to minimize discomfort to the patient.

The problem created by the presence of air in the passageway between thedispensing port of the cartridge and the nozzle of the catheter issolved by providing a vent tube which establishes communication betweenthe ambient atmosphere and the interior of the catheter nozzle. It hasbeen found that such a vent tube may serve its purpose even when it issufficiently restricted to prevent any significant diversion of theadvancing plastic along the vent path.

The problem of avoiding use of the dispensing port at the front end ofthe cartridge for carrying out the mixing operating is solved byextending a dasher-actuating rod through the dispensing piston from therear end of the cartridge thereby making the dispensing portcontinuously available.

The problem of enabling an operating rod initially to actuate the dasherindependently of the dispensing piston and subsequently to operate thedispensing piston is solved by slidingly mounting the operating rod inthe dispensing piston and by providing means to subsequently connect theoperating rod directly to the dispensing piston.

In the preferred practice of the invention the subsequently operablemeans comprises a circumferential groove in the operating rod, a snapring to seat in the groove and a manually operable push sleeve to shiftthe snap ring along the operating rod to the groove. After employing theoperating rod to reciprocate the dasher for thoroughly intermixing thetwo ingredients, it is a simple matter to retract the operating rod tobring the dasher into abutment with the leading face of the dispensingpiston and then to seat the snap ring in the groove at the rear face ofthe piston for fixedly connecting the piston to the operating rod.

The problem of providing the cartridge with a positively lockeddispensing valve that may be quickly unlocked at the end of the mixingoperation is solved by providing a valve member that protrudes throughthe dispensing port and is opened by axial retraction into thedispensing port. An easily removable locking collar normally embracesthe protruding portion of the valve member to keep the valve member inits extended closed position. It is a simple matter to remove thelocking collar to free the valve member for axial retraction to its openposition.

The problem enabling the dispensing valve to open in response to thestep of connecting the cartridge to the catheter is solved by making thevalve member hollow and by connecting the cartridge to the catheter bytelescoping the end of a connecting tube over the protruding end of thevalve member. Thus with the lock removed from the dispensing valvemember, the mere act of manually forcing the connecting tube over theend of .the valve member pushes the valve member rearward to its openposition.

Solving the above mentioned problems relating to the operation of thedispensing cartridge also solves the problem of making it possible toconnect the cartridge to the catheter in advance thereby to eliminatethe need to make the connection within the allowed thirty seconds. Atthe end of the mixing operation it is necessary merely to pull the valvelock free and then push the dispensing cartridge slightly forwardrelative to the connecting tube to retract the dispensing valve memberto its open position. There is no special need for making such aconnection in advance of the mixing operation, however, because of theabove described timesaving features of the dispensing cartridge and someoperators prefer to have the dispensing cartridge disconnected from thecatheter for greater freedom to perform the mixing operation.

The problem of producing the whole assembly so inexpensivelythat it maybe discarded after a single use is solved largely by making both thecatheter and the dispensing cartridge out of plastic parts that may bemolded on a mass production basis. In addition the various parts aredesigned to make possible a simple assembly procedure that requiresneither special skill nor special tools.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, which are to beregarded as merely illustrative;

FIG. 1 is a longitudinal sectional view of the device showing thedispensing container connected to the catheter;

FIG. 2 is a greatly enlarged longitudinal sectional view of thecatheter;

FIG. 3 is a longitudinal sectional view of the dispensing cartridgeserving as a multiple compartment container prior to use of the device;

FIG. 4 is a face view of the dasher in cartridge;

FIG. 5 is an enlarged fragmentary sectional view showing the valve atthe inner end of the hollow operating rod; the valve being in closedposition;

FIG. 6 is a view similar to FIG. 5 showing the valve in open position;

FIG. 7 is a fragmentary longitudinal sectional view showing theoperating rod retracted for the purpose of operatively connecting theoperating rod to the piston;

FIG. 8 is an enlarged longitudinal sectional view of the dispensing endof the cartridge with the dispensing valve closed and locked; and

FIG. 9 is a perspective view of the clip for locking the dispensingvalve in closed position.

the dispensing DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1illustrates the operation of injecting an uncured polymer into therectum of a patient to mold a replica of the interior configuration ofthe sigmoid colon. It is obvious that a rigid molded replica could notbe withdrawn from the colon whereas an exceedingly soft and flexiblereplica may be expelled by the patient.

The preferred embodiment of the invention shown complete in FIG. 1comprises the combination of a catheter, generally designated 10, and adispensing container, generally designated 12, that is releasablyconnected to the catheter by means of a flexible tube 14. It will beappreciated that both the catheter and the dispensing container may beof various constructions within the scope of the invention. A feature ofthe preferred practice of the invention is that both the catheter l0 andthe dispensing container 12 are disposable for discard after a singleuse.

The catheter has a one-piece molded body 15 of relatively rigid plasticmaterial, the body being of tubular configuration with an integralrearwardly flared guard flange 16. The forward end of the tubular body15 is formed with nozzle apertures 18 and the rear end of the tubularbody is telescoped into the forward end of the previously mentionedflexible tube 14. A feature of the invention is that the tubular body 15is embraced by a resilient absorbent collar 20 forward of the guardflange 16, which collar is preferably made of a suitable open-celledfoamed plastic with sponge-like characteristics. The guard flange 16limits the extent to which the catheter may be inserted into the bodycavity and the collar 20 not only serves as a cushion but also absorbsminor leakage of fluid from the body cavity during the injectionprocedure.

The tubular body 15 of the catheter 10 is provided with a cuff 22 ofrelatively thin elastomeric material which is deflated when the catheteris inserted into the body cavity and then is inflated to serve the dualpurpose of preventing inadvertent withdrawal of the catheter during theinjection operation and of blocking leakage of the polymer from the bodycavity during the operation. For the purpose of inflating the cuff 22when desired, a small flexible tube 24 extends from the interior of thecuff along an exterior groove 25 (FIG. 2) of the tubular body 15 andthrough the guard flange 16. The second end of the small tube isconnected to a bulb-type hand pump 26 of a well known type, the pumpbeing provided with a manually operable release valve 28. The catheteris inserted into the body cavity with the cuff 22 deflated and then thecuff is inflated by manual operation of the bulb-type pump. After theplastic replica cures, the release valve 28 is manipulated to deflatethe cuff in preparation for withdrawal of the catheter.

Preferably the catheter 10 is covered with a smooth layer 29 of asuitable material such as latex which extends from the nozzle end of thecatheter to the rim of the guard flange 16. The purpose of this layer isto provide a smooth surface for the catheter. In the construction shownthe tubular body 15 of the catheter is slightly reduced in diameter toform a rearwardly circumferential shoulder 30 against which the forwardedge of the layer 29 abuts in a flush manner.

In the preferred practice of the invention the catheter is provided witha small flexible vent tube 31. The forward end of the vent tube isinside the tubular body 15 near the nozzle apertures 18 and the tubeextends outward through an aperture 32 of the tubular body rearward ofthe guard flange 16. When the uncured plastic is advanced through theflexible tube 14 into the tubular body 15 of the catheter, the airdisplaced by the advancing polymer escapes to the atmosphere through thevent tube 31. The vent tube 31 is of sufficiently restricted internaldiameter to prevent any appreciable amount of the uncured polymer fromentering the tube after the air is expelled.

The container 12 is a disposable plastic cartridge which is providedwith a dispensing piston 34 for the purpose of extruding the uncuredplastic into the flexible tube 14 and through the catheter 10 into thebody cavity. The dispensing piston 34 is adapted to be actuated manuallyby a rearwardly extending operating rod that terminates in a handle orpalm knob 36.

A feature of the invention is that the dispensing container 12 alsoserves as a multiple compartment container to store the separateingredients of the plastic material prior to use of the device as adispensing means. FIG. 3 shows the dispensing container or disposablecartridge 12 in the form in which it is handled and shipped prior touse.

As shown in FIG. 3 the cartridge has a cylindrical shell of suitableplastic material, the shell being reduced in diameter at the front toform a nipple 38 that provides the discharge port of the container. Therear open end of the cylindrical shell is equipped with a ring 40 havingan axial opening 42 to clear the operating rod 35, the purpose of thering being to reinforce the rear end of the shell and to serve as a stopto prevent inadvertent withdrawal of the dispensing piston 34.

As shown in FIG. 3 the dispensing piston 34 is initially in a retractedposition to cooperate with the shell of the container to form a firstrelatively large compartment 44 for the silicone polymer. The operatingrod 35 is of hollow or tubular construction to form a second smallercompartment 45 for the required catalyst. For this purpose the outer endof the tubular operating rod 35 is closed by a small slidable plug 46which may be termed a second piston and the inner end of the tubularoperating rod is normally blocked by a valve member 48 which is adaptedto open in response to rise in pressure in the second compartment.

As shown in FIGS. 5 and 6, the inner end of the tubular operating rod 35is reduced in diameter to form an outlet port 50 and a tapered innercircumferential shoulder 52 leading to the outlet port. The valve member48 has a rear end enlargement 54 for guiding cooperation with the innerwall of the operating rod and has a forward end portion 55 which isformed with a slight circumferential enlargement 56 to seal off theoutlet port 50. The valve member 48 is formed with a passage 58 throughthe rear enlargement 54, the passage communicating with a longitudinalrecess 60 in one side of the valve member.

At the normal closed position of the valve member 48 shown in FIG. 5,the forward end portion 55 seals off the outlet port 50 of the tubularoperating rod. When the second piston 46 is manually advanced in thetubular operating rod, the consequent rise in fluid pressure of thecatalyst inside the operating rod causes the valve member 48 to beadvanced from its retracted closed position shown in FIG. to its forwardopen position shown in FIG. 6. Thus manually forcing the second piston46 forward to the region of the valve member 48 results in extrusion ofthe catalyst from the second compartment 45 into the first compartment44.

The preferred embodiment of the invention includes a ram rod 62 formedwith a palm knob 64 at one end, the ram rod being initially releasablytied to the dispensing container by means such as string 65. It iscontemplated that the length of the ram rod 62 will be such that whenthe palm knob 64 abuts the palm knob 36 of the operating rod 35, thesecond piston 46 will reach the open valve member 48 for substantially.complete extrusion of the catalyst into the first compartment 44.

The operating rod 35 is permanently connected at its inner end to adasher 66 which is of a suitable configuration for efficient mixingaction in response to reciprocation of the dasher by the operating rod35. As shown in FIG.4, the dasher 66 preferably has two openings 68 intwo of its quadrants, the remaining half of the dasher being blank. Theoperating rod 35 initially slidingly extends through the dispensingpiston 34 to permit reciprocation of the dasher 66 independently of thedispensing piston.

Any suitable means may be provided to fixedly connect the dispensingpiston 34 to the operating rod when the time arrives for using thepiston to dispense the mixed uncured polymer. In this particularembodiment of the invention the tubular operating rod 35 is providedwith a circumferential groove 70 to cooperate with a split snap ring 72and when it is desired to operate the dispensing piston 34, the snapring is advanced from a retracted position to a position seated in thegroove 70. At the seated position of the snap ring 72, the snap ringabuts the rear side of the dispensing piston and the forward side of thedispensing piston abuts the dasher 66. Thus the seated snap ring, ineffect clamps the dispensing piston 34 against the dasher 66.

A feature of this embodiment of the invention is the provision of aplastic sleeve 74 which loosely embraces the operating rod 35 to serveas manual means for pushing the snap ring 72 from its restrictedposition to its effective seated position. FIG. 3 shows the snap ring 72and the plastic sleeve 74 in their normal retracted positions. FIG. 7shows the tubular operating rod 35 fully retracted to bring the dasher66 against the front wall of the dispensing piston 34. With theoperating rod 35 fully retracted in this manner, it is a simple matterto advance the plastic sleeve 74 manually from its retracted position tothe position shown in solid lines in FIG. 7 for the purpose of advancingthe snap ring 72 into engagement with the circumferential groove 70.

The dispensing port at the forward nipple 38 of the dispensing cartridgemay be normally closed in any suitable manner. A feature of thisparticular embodiment of the invention is the use of a special valvemember 75 for this purpose which is tubular to permit dispensing flowtherethrough and which is adapted to serve as a fitting for connectingthe dispensing container to the previously mentioned flexible tube 14.

completely cuts off the dispensing port and when the As best shown inFIG. 8 the dispensing valve member is closed at its inner end by atransverse wall 76, and is further provided with a radial flange 78 atitsrear end which normally abuts the inner rim of the dispensing port.The valve member 75 is further provided with a radial port 80 which isnormally closed by the inner circumferential wall 82 of the dispensingport. A substantial portion of the valve member 75 protrudes forwardfrom the dispensing port of the container and the protruding portion ofthe valve member is formed with a rearwardly facing circumferentialshoulder 84 and a series of rearwardly inclined sharp ribs 85, whichribs serve as barbs for engagement with the inner circumferential wallof the flexible tube 14. It is.apparentin FIG. 8 that at the forwardposition of the valve member 75 that is shown in solid lines, the valvemember valve member is retracted to the position shown in dotted lineswith the shoulder 84 in abutment against the forward rim 86 of thenipple 38, the uncured plastic material may be extruded through thevalve member, the plastic material flowing into the radial port 80 ofthe valve member.

When the dispensing container is handled, stored and shipped prior touse, the dispensing valve member 75 is locked in its forward closedposition by means of a locking clip 88, the locking clip beinginterposed between the shoulder 84 of the valve member and the forwardrim 86 of the nipple 38. As best shown in FIG. 9 the locking clip 88 hasa curved body 90 dimensioned to extend more than half way around thevalve member 75. The locking clip is made of sufficiently resilientplastic material to yieldingly grip the valve member in a removablemanner-and the clip is formed with a ribbed tab 92 to serve as aconvenient handle for removing the clip.

The manner in which the described structure serves its purpose may bereadily understood from the foregoing description.

The catheter 10 with the flexible tube 14 connected thereto butseparated from the dispensing container 12 is inserted into the bodycavity and then the cuff 22 is inflated by means of the pump device 26.The first step in preparation for the injection operation is toreciprocate the dasher 15 for approximately fifteen full length strokesby means of the operating rod 35, stopping with the dasher approximatelyhalf way through the last stroke. When the polymer formula in the firstcompartment 44 stands for considerable period of time, there is atendency for segregation of the liquid and solid ingredients and thepurpose of this initial mixing action is to make the polymerhomogeneous.

The next step is to use the ram rod 62 to force the second piston 46forward in the tubular operating rod 35 thereby to move the valve member48 to open position for extrusion of the catalyst from the secondcompartment 45 into the first compartment 44. The ram rod is advanced tothe maximum to displace substantially all of the catalyst. Thedisplacement of the catalyst into the first compartment 44 starts thetime period of 30 seconds during which the two ingredients of theuncured plastic must be thoroughly intermixed. After this 30-second timeinterval the extrusion of the mixed plastic into the body cavity must becompleted within an additional time interval of seconds before theplastic starts to cure. Thorough intermixture of the two ingredients isrequired and is accomplished by reciprocating the operating rod 35 forits full length approximately times. The introduction of the catalystinto the first compartment 44 causes the dispensing piston 34 to retractslightly on the first stroke of the operating rod.

The mixing operation is terminated with the operating rod 35 fullyretracted and then the plastic sleeve 74 is advanced from the positionshown in FIG. 3 to the position shown in FIG. 7 for the purpose ofshifting and seating the snap ring 72 to anchor the dispensing piston 34to the operating rod.

The next step is to grasp the tab 92 of the locking clip 88 to removethe locking clip and thus free the dispensing valve 75. With the lockingclip removed, the

barbed end of the dispensing valve 74 is inserted into the end of theflexible tube 14. This act of forcing the dispensing valve member 75into the tube 14 causes retraction of the dispensing valve to its openposition in reaction to the applied force. Thus the operator is notrequired to take time to open the dispensing valve. With the dispensingvalve open, the operator advances the dispensing piston 34 to themaximum by means of the operating rod 35 to extrude the uncured plasticthrough the flexible tube 14 and through the catheter 10 into the bodycavity. After a short time, the release valve 28 of the bulb pump 26 maybe opened for deflation of the cuff 22 to permit withdrawal of thecatheter.

Our description in specific detail of the preferred embodiment of theinvention will suggest various changes, substitutions and otherdeparturesvfrom our disclosure within the spirit and scope of theappended claims.

We claim:

1. In a medical device of the character described for injecting anuncured fluent plastic material into a cavity of a patients body to becured therein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of:

A a catheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic;

a guard flange fixedly united with the catheter to limit the insertionof the injection nozzle;

an absorbent collar embracing the catheter forward of the guard flangefor confinement between the guard flange and the patients body when thecatheter is inserted into the cavity, said collar being made of a softporous material to serve as a cushion and to absorb and retain fluidsreleased from the cavity after the catheter is inserted and during theinjection operation; and

means to release to the atmosphere air that is displaced into thecatheter by the flow of plastic to the catheter thereby to prevent thedisplaced air from causing a misleading void in the molded replica.

2. In a medical device of the character described for injecting anuncured fluent plastic into a cavity of a patients body to be curedtherein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic;

means including a passage means to deliver uncured 5 plastic to thecatheter;

a hollow cuff embracing the catheter rearward of the tip of the nozzlefor inflation to close off the body cavity back of the nozzle during theinjection operation; and

means to release to the atmosphere air that is displaced from saidpassage means into the catheter by the advance of the plastic throughthe supply passage thereby to avoid entrapment of such displaced air inthe cavity as would prevent the plastic from filling the cavity.

3. A combination as set forth in claim 2 in which said means to releaseair has a flow passage of restricted cross section toprevent significantdiversion of the uncured plastic into the flow passage.

4. A combination as set forth in claim 2 which includes a passage meansconnected to the catheter and a cartridge connected at its front end tothe passage means,

said cartridge having a plurality of separate compartments to storeseparate ingredients of the uncured plastic,

said cartridge including a dasher operable from the rear end of thecartridge to intermix the ingredients to form the uncured plastic,

said cartridge including means to extrude the uncured plastic into thepassage means.

5. A combination as set forth in claim 2 in which said catheter hasaguard rearward of the nozzle tip fixedly secured thereto to limitinsertion of the catheter into the body cavity; and

in which said releasing means extends through the guard to the regionrearwardly thereof.

6. A combination as' set forth in claim 5 which includes an absorbentcollar embracing the catheter forward of the guard for confinementbetween the guard and a patients body when the catheter is inserted intothe cavity,

said collar being made of a soft porous material to serve as a cushionand to absorb and retain fluid released from the body cavity after thecatheter is inserted and during the injection operation.

7. A combination as set forth in claim 5 in which said catheter, hollowcuff and guard are covered by a layer of plastic material forming asmooth surface that is continuous from the region of the tip of theinjection nozzle to the rim of the guard.

8. A combination as set forth in claim 2 which includes a cartridgeconnected at its forward end to the catheter to deliver uncured plasticthereto,

said cartridge having a plurality of separate compartments to storeseparate ingredients of the uncured plastic,

said cartridge including a dasher manually operable from the rear end ofthe cartridge to intermix the ingredients to form the uncured plastic,

said cartridge including manually operable means to extrude the uncuredplastic into the catheter.

9. Means for intermixing a plurality of ingredients and then promptlydispensing the mixture, comprising:

said manually releasable means is a removable locking member inengagement both with the dispensing container and with the valve memberto hold the valve member in closed position.

said valve member has a peripheral rearwardly facing shoulder and saidcontainer forms a forwardly facing shoulder;

, said valve means being in the form of a tubular valve 1 memberslidingly telescoped into the dispensing port to control flowtherethrough,

said tubular valve member protruding from the dispensing port to form adispensing nozzle capable-of attachment to a flexible tube by insertionof the valve member into the end of the tube,

said tubular valve member being axially retractable from a forwardclosed position to a rearward open position.

10. A combination as set forth in claim 9 which ineludes manuallyreleasable means to retain the valve member normally at its forwardclosed position.

11. A combination as set forth in claim 10 in which 12. A combination asset forth in claim ll in which and then promptly dispensing the mixture,comprising:

a dispensing container having a forward end and-a rearward end with anormally closed dispensing port inthe forward end;

a dispensing piston in said dispensing container defining therewith afirst ingredient-containing compartment in communication with thedispensing port;

a dasher in said first compartment;

a manually operable rod extending from the dasher through the piston tothe rear end of the dispensing container to actuate the dasherindependently of the piston,

said rod being hollow to form a second ingredientcontaining compartment;

means operable from the rear end of the operating rod to extrude thecontent of said second compartment into the first compartment; and

manual means to operatively connect the piston to the rod member foractuation of the piston by the rod member to extrude the mixedingredients from the first compartment through the dispensing port.

14. A combination as set forth in claim 13 which ineludes:

a normally closed valve at the inner end of the hollow rod, said valvebeing responsive to pressure in thehollow rod to open in response torise in the pressure; and

a second piston normally closing the outer end of the hollow rod,whereby said second piston may be manually advanced towardssaidpressure-responsive valve to create pressure within the hollow' rodmember to open the pressure-responsive valve and then to displace thecontent of the second compartment into the first compartment.

15. Means for intermixing at least two ingredients and then dispensingthe mixture, comprising:

a container having compartments to store the ingredients separately,said container having a forward dispensing port and having a rearwardpiston serving as a rear wall for one of the compartments;

means to place the compartments in communication with each other tobring the ingredients into mu tual contact;

a dasher to intermix the mutually contacting ingredients; Y

a manually operable rod slidingly extending through the rearward pistonto reciprocate said dasher; and

manually operable means to connect the piston to the rod for actuationof the piston by the rod to extrude the mixed ingredients from thecontainer through the dispensing port,

said means to operatively connect the rod to the piston comprising:

shoulder means on the periphery of the rod;

and a cooperative retainer element outside of the container slidinglymounted on the rod and normally spaced from said shoulder means,

said retainer element being manually movable into engagement both withsaid shoulder means and with the piston'for the purpose of operativelyconnecting the piston to the rod.

16. A combination as set forth in claim 15 in which said retainerelement is slidingly mounted on the rod and which includes a sleeveslidingly embracing the rod to serve as manual means for pushing theretainer element from its normal position to a position in engagementwith said shoulder means.

17. A combination as set forth in claim 15 in which said shoulder meanscomprises a circumferential groove on the periphery of the rod and saidretainer element is a snap ring slidingly embracing the rod.

18. A combination as set forth in claim 17 which includes a sleeveslidingly embracing the rod, said sleeve being manually operable to pushsaid snap ring into said circumferential groove.

19. In a medical device of the character described for injecting anuncured fluent plastic material into a cavity of a patients body to becured therein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic;

a dispensing container having a forward dispensing port connected tosaid catheter;

said container having multiple compartments for multiple ingredients ofthe mixture;

means operable from the rear end of the dispensing container to bringsaid ingredients together;

a dasher operable from the rear end of the dispensing container tointermix the ingredients;

manual means operable from the rear end of the dispensing container toextrude the ingredients manually through said dispensing port; and

means to prevent extrusion from the dispensing container while thedispensing container is connected to the catheter when the dasher is inoperation.

20. In a medical device of the character described for injecting anuncured fluent plastic material into a cavity of a patients body to becured therein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic;

a dispensing container having a forward end with a dispensing port forconnection with the catheter;

a dispensing piston in said dispensing container defining therewith afirst ingredient-containing compartment in communication with thedispensing port;

a dasher in said first compartment;

a manually operable rod extending from the dasher through the piston tothe rear end of the dispensing container to actuate the dasherindependently of the piston,

said rod being hollow to form a second ingredientcontaining compartment;

means operable from the rear end of the operating rod to extrude thecontent of said second compartment into the first compartment; and

manual means to operatively connect the piston to the rod member foractuation of the piston by the rod member to extrude the mixedingredients from the first compartment through the dispensing port.

21. In a device for injecting an uncured plastic into a cavity to formtherein a replica of the cavity that is sufficiently resilientlydeformable to permit withdrawal of the replica without destroying theconfiguration of the replica, the combination of:

a catheter for insertion into the cavity;

a dispensing container having a forward end and a rearward end with adispensing port in the forward end;

said container having multiple compartments for multiple ingredients ofthe plastic;

means operable from the rear end of the dispensing container to bringsaid ingredients together;

means operable from the rear end of the dispensing container to intermixthe ingredients;

means operable from the rear end of the dispensing container to extrudethe ingredients through said dispensing port;

a hollow valve member slidingly mounted in the dispensing port andprotruding axially from the dispensing port to serve as a dispensingnozzle; and

a flexible tube having one end telescoped over said hollow valve memberand having its other end connected to the catheter to place thedispensing container in flow communication with the catheter,

said hollow valve member being axially retractable from a forward closedposition to a rearward open position,

whereby manually telescoping the end of the tube over the hollow valvemember involves applying axial force to the valve member to retract thevalve member to its open position.

22. In a medical device of the character described for injecting anuncured fluent plastic into a cavity of a pateients body to be curedtherein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity which includes a catheterfor insertion into the cavity and means to extrude the fluent plasticinto the cavity through the catheter,

the improvement comprising:

means to release to the atmosphere air that is displaced from theinterior of the catheter by initial.

advance of the extruded plastic thereby to 'avoid forcing the displacedair into the cavity and consequent failure of the plastic tosubstantially completely fill the cavity.

23. In a method of diagnosing the condition of a cavity of a livingperson wherein a catheter with a passage therethrough is inserted intothe cavity and uncured plastic material is extruded through said passageinto the cavity to result in a soft resilient flexible replica of theconfiguration of the interior of the cavity, and wherein escape of theplastic material from the cavity along the outer surface of the catheteris blocked,

the'improvement comprising:

venting air from said passage of the catheter to the atmosphere as theplastic material progressively occupies the passage thereby to preventthe air from being forced into the cavity with consequent failure of theplastic material to substantially completely fill the cavity.

24. In a medical device of the character described for injecting anuncured fluent plastic into a cavity of a patients body to be curedtherein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity for injection the uncuredplastic into the cavity through the catheter;

a hollow cuff embracing the catheter rearward of the leading end of thecatheter for inflation to close off the body cavity back of the leadingend of the catheter during the injection operation;

a cartridge containing a supply body of the uncured plastic,

said cartridge having a dispensing port;

a tubular valve member in the dispensing port protruding therefrom toserve as a nozzle for the cartridge;

a flexible tube connecting the tubular valve member to the catheter, theupstream end of the tube being telescoped over the tubular valve member,

the tubular valve member being retractable from a forward closedposition to a rearward open position whereby manually telescoping theupstream end of the tube over the protruding end of the tubular valvemember involves applying axial force to the valve member to retract thevalve member to its open position;

means to extrude the uncured plastic from the container to the catheterthrough said dispensing port, said tubular valve member and through theflexible tube; and

a vent tube placing the interior of the catheter near its leading end incommunication with the 'atlO60l2 0041

1. In a medical device of the character described for injecting anuncured fluent plastic material into a cavity of a patient''s body to becured therein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of: acatheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic; a guard flangefixedly united with the catheter to limit the insertion of the injectionnozzle; an absorbent collar embracing the catheter forward of the guardflange for confinement between the guard flange and the patient''s bodywhen the catheter is inserted into the cavity, said collar being made ofa soft porous material to serve as a cushion and to absorb and retainfluids released from the cavity after the catheter is inserted andduring the injection operation; and means to release to the atmosphereair that is displaced into the catheter by the flow of plastic to thecatheter thereby to prevent the displaced air from causing a misleadingvoid in the molded replica.
 2. In a medical device of the characterdescribed for injecting an uncured fluent plastic into a cavity of apatient''s body to be cured therein to form a soft resiliently flexiblemolded replica of the configuration of the interior of the cavity, thecombination of: a catheter for insertion into the cavity, said catheterincluding an injection nozzle for introduction of the uncured plastic;means including a passage means to deliver uncured plastic to thecatheter; a hollow cuff embracing the catheter rearward of the tip ofthe nozzle for inflation to close off the body cavity back of the nozzleduring the injection operation; and means to release to the atmosphereair that is displaced from said passage means into the catheter by theadvance of the plastic through the supply passage thereby to avoidentrApment of such displaced air in the cavity as would prevent theplastic from filling the cavity.
 3. A combination as set forth in claim2 in which said means to release air has a flow passage of restrictedcross section to prevent significant diversion of the uncured plasticinto the flow passage.
 4. A combination as set forth in claim 2 whichincludes a passage means connected to the catheter and a cartridgeconnected at its front end to the passage means, said cartridge having aplurality of separate compartments to store separate ingredients of theuncured plastic, said cartridge including a dasher operable from therear end of the cartridge to intermix the ingredients to form theuncured plastic, said cartridge including means to extrude the uncuredplastic into the passage means.
 5. A combination as set forth in claim 2in which said catheter has a guard rearward of the nozzle tip fixedlysecured thereto to limit insertion of the catheter into the body cavity;and in which said releasing means extends through the guard to theregion rearwardly thereof.
 6. A combination as set forth in claim 5which includes an absorbent collar embracing the catheter forward of theguard for confinement between the guard and a patient''s body when thecatheter is inserted into the cavity, said collar being made of a softporous material to serve as a cushion and to absorb and retain fluidreleased from the body cavity after the catheter is inserted and duringthe injection operation.
 7. A combination as set forth in claim 5 inwhich said catheter, hollow cuff and guard are covered by a layer ofplastic material forming a smooth surface that is continuous from theregion of the tip of the injection nozzle to the rim of the guard.
 8. Acombination as set forth in claim 2 which includes a cartridge connectedat its forward end to the catheter to deliver uncured plastic thereto,said cartridge having a plurality of separate compartments to storeseparate ingredients of the uncured plastic, said cartridge including adasher manually operable from the rear end of the cartridge to intermixthe ingredients to form the uncured plastic, said cartridge includingmanually operable means to extrude the uncured plastic into thecatheter.
 9. Means for intermixing a plurality of ingredients and thenpromptly dispensing the mixture, comprising: a dispensing containerhaving a forward end and a rearward end with a normally closeddispensing port in the forward end, said container having multiplecompartments for multiple ingredients of the mixture; means operablefrom the rear end of the dispensing container to bring said ingredientstogether; dasher means operable from the rear end of the dispensingcontainer to intermix the ingredients; means operable from the rear endof the dispensing container to extrude the ingredients through saiddispensing port; and valve means normally closing said dispensing port,said valve means being in the form of a tubular valve member slidinglytelescoped into the dispensing port to control flow therethrough, saidtubular valve member protruding from the dispensing port to form adispensing nozzle capable of attachment to a flexible tube by insertionof the valve member into the end of the tube, said tubular valve memberbeing axially retractable from a forward closed position to a rearwardopen position.
 10. A combination as set forth in claim 9 which includesmanually releasable means to retain the valve member normally at itsforward closed position.
 11. A combination as set forth in claim 10 inwhich said manually releasable means is a removable locking member inengagement both with the dispensing container and with the valve memberto hold the valve member in closed position.
 12. A combination as setforth in claim 11 in which said valve member has a peripheral rearwardlyfacing shoulder and said container forms a forwardly facing shoulder;AND in which said locking member is a U-shaped member to releasablyembrace the valve member with opposite sides of the U-shaped member inabutment with said two shoulders respectively.
 13. Means for intermixinga plurality of ingredients and then promptly dispensing the mixture,comprising: a dispensing container having a forward end and a rearwardend with a normally closed dispensing port in the forward end; adispensing piston in said dispensing container defining therewith afirst ingredient-containing compartment in communication with thedispensing port; a dasher in said first compartment; a manually operablerod extending from the dasher through the piston to the rear end of thedispensing container to actuate the dasher independently of the piston,said rod being hollow to form a second ingredient-containingcompartment; means operable from the rear end of the operating rod toextrude the content of said second compartment into the firstcompartment; and manual means to operatively connect the piston to therod member for actuation of the piston by the rod member to extrude themixed ingredients from the first compartment through the dispensingport.
 14. A combination as set forth in claim 13 which includes: anormally closed valve at the inner end of the hollow rod, said valvebeing responsive to pressure in the hollow rod to open in response torise in the pressure; and a second piston normally closing the outer endof the hollow rod, whereby said second piston may be manually advancedtowards said pressure-responsive valve to create pressure within thehollow rod member to open the pressure-responsive valve and then todisplace the content of the second compartment into the firstcompartment.
 15. Means for intermixing at least two ingredients and thendispensing the mixture, comprising: a container having compartments tostore the ingredients separately, said container having a forwarddispensing port and having a rearward piston serving as a rear wall forone of the compartments; means to place the compartments incommunication with each other to bring the ingredients into mutualcontact; a dasher to intermix the mutually contacting ingredients; amanually operable rod slidingly extending through the rearward piston toreciprocate said dasher; and manually operable means to connect thepiston to the rod for actuation of the piston by the rod to extrude themixed ingredients from the container through the dispensing port, saidmeans to operatively connect the rod to the piston comprising: shouldermeans on the periphery of the rod; and a cooperative retainer elementoutside of the container slidingly mounted on the rod and normallyspaced from said shoulder means, said retainer element being manuallymovable into engagement both with said shoulder means and with thepiston for the purpose of operatively connecting the piston to the rod.16. A combination as set forth in claim 15 in which said retainerelement is slidingly mounted on the rod and which includes a sleeveslidingly embracing the rod to serve as manual means for pushing theretainer element from its normal position to a position in engagementwith said shoulder means.
 17. A combination as set forth in claim 15 inwhich said shoulder means comprises a circumferential groove on theperiphery of the rod and said retainer element is a snap ring slidinglyembracing the rod.
 18. A combination as set forth in claim 17 whichincludes a sleeve slidingly embracing the rod, said sleeve beingmanually operable to push said snap ring into said circumferentialgroove.
 19. In a medical device of the character described for injectingan uncured fluent plastic material into a cavity of a patient''s body tobe cured therein to form a soft resiliently flexible molded replica ofthe configuration of the interior of the cavity, the combination of: acatheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic; a dispensingcontainer having a forward dispensing port connected to said catheter;said container having multiple compartments for multiple ingredients ofthe mixture; means operable from the rear end of the dispensingcontainer to bring said ingredients together; a dasher operable from therear end of the dispensing container to intermix the ingredients; manualmeans operable from the rear end of the dispensing container to extrudethe ingredients manually through said dispensing port; and means toprevent extrusion from the dispensing container while the dispensingcontainer is connected to the catheter when the dasher is in operation.20. In a medical device of the character described for injecting anuncured fluent plastic material into a cavity of a patient''s body to becured therein to form a soft resiliently flexible molded replica of theconfiguration of the interior of the cavity, the combination of: acatheter for insertion into the cavity, said catheter including aninjection nozzle for introduction of the uncured plastic; a dispensingcontainer having a forward end with a dispensing port for connectionwith the catheter; a dispensing piston in said dispensing containerdefining therewith a first ingredient-containing compartment incommunication with the dispensing port; a dasher in said firstcompartment; a manually operable rod extending from the dasher throughthe piston to the rear end of the dispensing container to actuate thedasher independently of the piston, said rod being hollow to form asecond ingredient-containing compartment; means operable from the rearend of the operating rod to extrude the content of said secondcompartment into the first compartment; and manual means to operativelyconnect the piston to the rod member for actuation of the piston by therod member to extrude the mixed ingredients from the first compartmentthrough the dispensing port.
 21. In a device for injecting an uncuredplastic into a cavity to form therein a replica of the cavity that issufficiently resiliently deformable to permit withdrawal of the replicawithout destroying the configuration of the replica, the combination of:a catheter for insertion into the cavity; a dispensing container havinga forward end and a rearward end with a dispensing port in the forwardend; said container having multiple compartments for multipleingredients of the plastic; means operable from the rear end of thedispensing container to bring said ingredients together; means operablefrom the rear end of the dispensing container to intermix theingredients; means operable from the rear end of the dispensingcontainer to extrude the ingredients through said dispensing port; ahollow valve member slidingly mounted in the dispensing port andprotruding axially from the dispensing port to serve as a dispensingnozzle; and a flexible tube having one end telescoped over said hollowvalve member and having its other end connected to the catheter to placethe dispensing container in flow communication with the catheter, saidhollow valve member being axially retractable from a forward closedposition to a rearward open position, whereby manually telescoping theend of the tube over the hollow valve member involves applying axialforce to the valve member to retract the valve member to its openposition.
 22. In a medical device of the character described forinjecting an uncured fluent plastic into a cavity of a pateient''s bodyto be cured therein to form a soft resiliently flexible molded replicaof the configuration of the interior of the cavity which includes acatheter for insertion into the cavity and means to extrude the fluentplastic into the cavity through the catheter, the improvementcomprising: means to release to the atmosphere air that is displacedfrom the Interior of the catheter by initial advance of the extrudedplastic thereby to avoid forcing the displaced air into the cavity andconsequent failure of the plastic to substantially completely fill thecavity.
 23. In a method of diagnosing the condition of a cavity of aliving person wherein a catheter with a passage therethrough is insertedinto the cavity and uncured plastic material is extruded through saidpassage into the cavity to result in a soft resilient flexible replicaof the configuration of the interior of the cavity, and wherein escapeof the plastic material from the cavity along the outer surface of thecatheter is blocked, the improvement comprising: venting air from saidpassage of the catheter to the atmosphere as the plastic materialprogressively occupies the passage thereby to prevent the air from beingforced into the cavity with consequent failure of the plastic materialto substantially completely fill the cavity.
 24. In a medical device ofthe character described for injecting an uncured fluent plastic into acavity of a patient''s body to be cured therein to form a softresiliently flexible molded replica of the configuration of the interiorof the cavity, the combination of: a catheter for insertion into thecavity for injection the uncured plastic into the cavity through thecatheter; a hollow cuff embracing the catheter rearward of the leadingend of the catheter for inflation to close off the body cavity back ofthe leading end of the catheter during the injection operation; acartridge containing a supply body of the uncured plastic, saidcartridge having a dispensing port; a tubular valve member in thedispensing port protruding therefrom to serve as a nozzle for thecartridge; a flexible tube connecting the tubular valve member to thecatheter, the upstream end of the tube being telescoped over the tubularvalve member, the tubular valve member being retractable from a forwardclosed position to a rearward open position whereby manually telescopingthe upstream end of the tube over the protruding end of the tubularvalve member involves applying axial force to the valve member toretract the valve member to its open position; means to extrude theuncured plastic from the container to the catheter through saiddispensing port, said tubular valve member and through the flexibletube; and a vent tube placing the interior of the catheter near itsleading end in communication with the atmosphere to release to theatmosphere air that is displaced from said flexible tube by the advanceof the plastic through the flexible tube thereby to avoid suchentrapment of displacement air in the cavity as would keep the plasticfrom substantially filling the cavity.